DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a 371 of PCT/US2020/029122 filed 04/21/2020 which claims benefit of provisional application 62/837,328 filed 04/23/2019. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Status of the Claims
Claims 1, 4, 5, 6, 9, 10 and 34 were amended. Claims 7 and 8 were cancelled.
Claims 1, 4-6, 9, 10, 12-27 and 34 are pending. Claims 17-27 are withdrawn.
Claims 1, 4-6, 9, 10, 12-16 and 34 (claim set filed 11/04/2025) are examined on the merits herein.
Withdrawal of Rejections
The response and amendment filed on 11/04/2025 are acknowledged. All of the amendment and arguments have been thoroughly reviewed and considered.
For the purposes of clarity of the record, the reasons for the Examiner's withdrawal and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner's response to arguments section.
The previous claims 1, 4, 5, 9, 10 and 12-16 rejection under 35 U.S.C. 112(b) has been withdrawn necessitated by amendment of claims 1, 4, 5, 9 and 10.
Sequence Interpretation
Claim 1 is directed to a variant polypeptide of the beta-amylase according to SEQ ID NO. 1. Claim 1 recites the limitations for the sequence of the polypeptide to comprise first amino acid substitutions and at least one second amino acid modification at an amino acid residue selected from the recited group. Claim 1 is interpreted as directed to a variant polypeptide having 6 first amino acid substitutions of the sequence with SEQ ID NO. 1, at least one second amino acid modification and that the variant polypeptide can include any additional modifications due to transitional phrase “comprises”.
Maintained rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-6, 9, 10, 12-16 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation for a variant polypeptide of the beta-amylase to have six first amino acid substitutions and at least one second amino acid modification at an amino acid residue selected from the recited group according to SEQ ID NO:1. As described above, claim 1 is interpreted as directed to the variant polypeptide that can have any modifications of SEQ ID NO:1 besides those included in the limitations. At the same time the variant polypeptide has limitation of having beta-amylase activity.
Thus, claim 1 broadly encompasses a genus of variant polypeptides of the beta-amylase. This would represent a large pool of variant protein sequences for beta-amylase that are functional. The Specification describes the wild-type beta-amylase as thermophilic B-amylase from Clostridium thermosulfurogenes (p. 39, lines 4-6) and teaches creation of variant beta-amylase polypeptides by enzyme evolution technique using Gene Site Saturation Mutagenesis (p. 39, lines 13-16). Mutations of 37 amino acid residues or their combinations from total of 519 residues are claimed and analyzed. However, the Specification does not provide structure function correlation for the beta-amylase and does not describe domains and/or amino acid residues essential for the beta-amylase function and domain and/or amino acid residues which can be modified without loss of function other than randomly selected and validated 37 amino acid residues representing about 7% of the complete sequence.
Thus, one of ordinary skill in the art would not be able to identify without further testing which amino acid sequences encode for functional beta-amylase. One of ordinary skill in the art would conclude based on the lack of describing the domains or amino acid residues of SEQ ID NO:1 critical for the function of beta-amylase that the Applicant was not in possession of the claimed genus and that the specification fails to satisfy the requirements of written description under 35 U.S.C. 112 (a).
Claims 4-6, 9, 10, 12-16 and 34 do not resolve the issue mentioned above and are rejected.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments (addressing p. 8 of the Remarks) that amendment “from the group consisting of” “clarifies and narrows the possible amino acid modifications to only those in variants with beta-amylase activity, as described in the specification. Each claimed amino acid modification has been tested for beta-amylase activity; see, for example, Table 1 listing 39 different variants, Table 2 listing 7 additional variants, and Tables 3 and 4 list an additional 74 variants with beta-amylase activity.”, these arguments are not persuasive because:
Claim 1 recites: “the variant polypeptide comprises first amino acid modifications and at least one second amino acid modification to the sequence according to SEQ ID NO: 1”. Modifications of 6 amino acid residues are recited for the first modification and a group of 31 amino acid residue position is recited for the second modification. The amendment “from the group consisting of” refers to the group of amino acid position numbers for the second amino acid modification and thus clarifies and narrows the amino acid position numbers for the second modification only. However, the transitional phrase “comprises” for the variant polypeptide does not exclude additional modifications of the polypeptide besides the first and the second modifications. Claim 1 is interpreted as directed to the variant polypeptide that can have any modifications of SEQ ID NO:1 besides those included in the limitations for the first and second amino acid modifications due to transitional phrase “comprises”. At the same time the variant polypeptide has the limitation of having beta-amylase activity. Therefore, claim 1 is directed to a large genus of variant polypeptides having beta-amylase activity. The specification does not provide the structure-function correlation for beta-amylase with SEQ ID NO: 1 and does not describe domains and/or amino acid residues critical for the beta-amylase function.
The MPEP 2163 states: "[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated." Tables 1-4 describe 74 variants with the beta-amylase activity as noted by Applicant, however, these variants are various mutations of 37 amino acid residues or their combinations from total of 519 residues that represents only about 7% of the amino acid residues. Thus, it cannot be predicted without knowing structure-function relationship that modification of other 93% of amino acid residues would provide functional beta-amylase polypeptide variant. Therefore, the 35 U.S.C.112 (a) rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653